Recalls / Brands / Fluocinolone Acetonide

Fluocinolone Acetonide

9 FDA drug recalls involving brand “Fluocinolone Acetonide”.

Date	Class	Product	Firm
2025-12-30	Class III	Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist. by: Taro Pharmaceut	SUN PHARMACEUTICAL INDUSTRIES INC
2024-01-04	Class II	Fluocinolone Acetonide Oil, 0.01% (Ear Drops), package in 1 Oz. (20 mL fill volume) bottle, Rx only, Manufactu	Glenmark Pharmaceuticals Inc., USA
2019-01-15	Class II	Fluocinolone Acetonide Topical Solution, USP, 0.01 %, 60 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceu	LUPIN SOMERSET
2018-10-05	Class II	Fluocinolone Acetonide Topical Solution, USP 0.01%, 60ml Bottle, Manufactured for: Lupin Pharmaceutical, Inc.	LUPIN SOMERSET
2018-04-13	Class II	Fluocinolone Acetonide Topical Oil, 0.01% (Ear Drops) 20 mL, Rx Only, Manufactured by: Lyne Laboratories, Inc.	Lyne Laboratories, Inc.
2018-04-13	Class II	Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil) 118.28 mL (4 fl. oz.) Rx Only, Manufactured by: Lyne Labo	Lyne Laboratories, Inc.
2018-04-13	Class II	Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil) 118.28 mL (4 fl.oz.) Rx Only, Manufactured by: Lyne Labo	Lyne Laboratories, Inc.
2017-02-22	Class III	Fluocinolone Acetonide Topical Solution USP 0.01% For Topical Use Only, Not for Ophthalmic Use, 60 mL bottle,	Novel Laboratories, Inc.
2013-09-30	Class III	G & W Fluocinolone Acetonide Cream USP 0.025%, a) 15 gm (NDC 0713-0222-15), b) 60 gm (NDC 0713-0222-60 ), Rx O	G & W Laboratories Inc